FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tobii Dynavox
DI: 07340074601301
·
Model: SC Tablet
·
TOBII DYNAVOX LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tobii Dynavox
- Primary DI
- 07340074601301
- Version / Model
- SC Tablet
- Catalog Number
- 800708
- Company Name
- TOBII DYNAVOX LLC
- Labeler DUNS
- 119127942
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-27
- Public Version
- 2
- Public Version Date
- 2022-09-02
- Public Version Status
- Update
- Public Device Record Key
- 535e8e20-f342-4a94-91cf-d1c4cb53429e
- Distribution End Date
- 2021-10-22
Device Description
SC TABLET, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/SILVER TABLET
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILQ | System, Communication, Powered | Physical Medicine | 890.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17187 | Voice synthesizer/digitizer | An assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07340074601301 | GS1 |
Customer Contacts
- Phone
- 800-344-1778
- [email protected]